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Stopping empirical antifungal therapy early based on a predefined set of criteria in children with high risk febrile neutropenia is safe: a randomized feasibility trial

Early Discontinuation Of Empirical Anti-Fungal Therapy In Children With High-Risk Febrile Neutropenia- A Randomised Feasibility Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/02/031563
Enrollment
30
Registered
2021-02-25
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: B49- Unspecified mycosis

Interventions

Intervention1: Early anti-fungal discontrinuation: When clinical criteria are fulfilled (no clinical evidence of fungal infection, hemodynamically stable) and a defined set of investigations are negat

Sponsors

All India Institute of Medical Sciences New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Having high risk febrile neutropenia and being started on empirical anti-fungals

Exclusion criteria

Exclusion criteria: 1.Treatment with therapeutic antifungal in the preceding 14 days 2.Residence >1 hour of reach from the hospital 3.Non-availability of reliable and compliant caretaker

Design outcomes

Primary

MeasureTime frame
Breakthrough fungal infectionTimepoint: 28 days from randomisation—

Secondary

MeasureTime frame
All cause mortalityTimepoint: 28 days from randomisation;Antifungal free daysTimepoint: 28 days from randomisation;Rehospitalization rateTimepoint: 28 days from randomisation—

Countries

India

Contacts

Public ContactMeena H

All India Institute of Medical Sciences, New Delhi

drjpmeena@gmail.com8890139358

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026